Medical Device Link.

Originally Published PMPN March 2004

Clinical Trials

Daphne Allen

Patients are usually kept in the dark during clinical trials. This is intentional, of course, to protect against bias that could affect drug outcomes. But, even though patients should know nothing about the clinical drug products, they do need to know how to follow regimens.

Child-resistant packaging that is easy to open and labeling that is easy to read and understand are necessities, says David Bernstein, vice president of pharmaceutical sciences and regulatory compliance for Cato Research West (Oakland, CA). “If a label simply reads, ‘Take two tablets daily,’ what will patients make of it? Does it mean one tablet every 12 hours or two tablets at a time? Instructions need to be very clear.”

Dorothy L. Smith, Pharm.D. and president and CEO of Consumer Health Information Corp. (McLean, VA), agrees. Her firm specializes in developing patient compliance strategies for products as they progress through Phase III and product launch. Here are her answers to better packaging during clinical trials.

How important is packaging to patient compliance?

Extremely important. The type of packaging that a company develops for its products can definitely help increase patient compliance. The information on the packaging is the last chance the pharmaceutical company has before the patient removes the medication to administer it. Patients forget approximately 50% of the information given to them by the physicians and do not understand many of the written materials they are given about the drugs and devices or disease management. Thus, the packaging can be developed so the most critical patient information is right there for the patient to read before taking the drug. Otherwise, patients will become confused and make errors.

What types of packaging help patients follow regimens?

The packaging is important in all phases of a product’s usage. Packaging is important in clinical trials because patient compliance is a “hidden problem.” When patients do not take the Phase III product correctly, the clinical investigators will be basing their conclusions (including the recommended dose) on inaccurate information. 

What should drug packagers do differently in the future to encourage compliance?

Packagers need to develop a sound patient compliance strategy during Phase III clinical trials. Determine what the patient compliance problems are going to be with your product and then develop strategies that will work. Refine the strategy as the product moves to product launch and then as the product enters the post launch phase. Patients need different types of patient education interventions at different stages during their treatments.

Can you point to any recent examples of drug packaging that encourage compliance?

We have worked with companies to develop completely integrated patient compliance programs for their products in Phase III. All of the patient education materials ranging from Informed Consent documents to patient materials, videos, and packaging were based on the patient compliance strategy. All materials were written and designed so that they would be understandable to patients. The packaging was developed to reinforce the key messages. The selection of color was extremely important because of its impact on patient compliance. A patient package insert (PPI) was developed for every program so that patients in the trial would understand “how to take and manage the study medication. By developing a PPI for Phase III usage, companies can pretest the PPI before submitting to FDA. 

Compliance packaging works. It makes the final delivery of the medication to the patient more patient-friendly and ties together the entire patient education program both during clinical trials and product launch. It shows consumers that drug company is doing everything it can to make the product easy to understand. And the ROI is significantly increased because patient retention increases.

Copyright ©2004 Pharmaceutical & Medical Packaging News